MAUDE Adverse Event Report: CARDINAL HEALTH PWRCORD W ADAPT 584491 KANGAROO CON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 584491

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Electric Shock (2554)

Event Date 06/14/2022

Event Type  Injury  

Event Description

The customer reported the staff member was relocating the feeding trolley and charger.The feeding trolley was in one hand and with the other hand they pulled the power adapter out from the wall.As the adapter was pulled off the wall, the staff member received an electric shock and shook the adapter from their hand causing it to fall on the ground.This staff member was unsure whether the adapter had the cover on it or not when it was unplugged from the wall.The power was definitely turned off on the wall (power outlets were turned off on the medical panel).What is unsure is if the shock happened with the cover on it and the cover broke off when it dropped to the ground or if the cover was loose or broken already.Additional information received: the staff member received a burn to her hand, abnormal heart activity, shock received to all of her body.She had an entry exit wound on her hand.She went to the emergency department and had bloods drawn, an ecg, and an ultrasound due to pregnancy.She was prescribed panadol.

Manufacturer Narrative

No serial number or lot information was provided, therefore, a device history record (dhr) review could not be performed and verified.All power cords are tested as per validated testing requirements prior to releasing for shipment from the supplier.No physical sample was received for evaluation.The customer provided sample photos.Because the physical device was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition or determine the root cause of the event.If the device is received later, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) could not be performed because no serial/lot number was available.This is an accessory part which is provided by a supplier.The supplier checked their testing results, and no abnormality was found.All power cords were tested as per validated testing requirements prior to releasing for shipment.No physical sample was returned for evaluation.The customer has provided sample photos.However, no further investigation could be conducted to determine the root cause without the physical sample.There is no corrective action required as this has not been determined to be a manufacturing induced issue.This complaint will be used for tracking and trending purposes.

• Brand Name: PWRCORD W ADAPT 584491 KANGAROO CON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15292599
• MDR Text Key: 298569796
• Report Number: 1282497-2022-10716
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 584491
• Device Catalogue Number: 584491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female